1. Field of the Invention
The present invention relates generally to devices for applying localized liquid therapy and/or thermotherapy to an afflicted area of the patient. More particularly, this invention relates to a device, and method of use thereof, which directly applies a liquid, most usually a water based liquid to a selected area to create the desired therapeutic effect, most usually a localized hyperthermia, which is effective in treating localized afflictions, such as moles, lesions, tumors, malignancies, both surface and subcutaneous, and the like, or a therapeutic lavage or irrigation.
2. Description of Related Art
Heat and cold have both been used to effectively treat afflicted patients. Directly applying liquid to afflicted cells is also well known. Cold has often been used as a localized treatment, while heat has been, and is currently used as both a localized and total body treatment. Using heat to treat a localized afflicted area of an afflicted patient is most relevant to the present invention.
The search continues to ways to effectively treat wounds, tumors and similar disorders while minimizing adverse collateral effects. For example, assignee has been a leader in treating open wounds through a process known as Vacuum Assisted Closure™ (“V.A.C.®”). In a similar vein, localized thermotherapy, primarily localized hyperthermia, has also shown promise as a treatment modality which is capable of producing beneficial therapeutic effects without significant adverse collateral effects for certain conditions. However, the localized hyperthermic treatment modalities in the prior art, all suffer from serious drawbacks, limitations, or side effects.
Research has demonstrated that heating cancerous, or other abnormal cells to over about 42° Celsius (“C”) can kill the abnormal cells, while causing little damage to the surrounding normal cells. This treatment is temperature sensitive. Heating the cancel cells, for example, to a temperature between nominal body temperatures, 37° C. and approximately 41° C. or greater can seriously damage them. To maximize patient safety, this hyperthermia treatment must be localized.
The variety of available heat transfer methods for localized thermotherapy is limited. Heat is transferred in three ways, radiation, convection, or conduction. The heat transfer medium creating the localized hyperthermia can be either heated in situ or be heated exogenously, before being placed upon the patient. The medium can either be placed in direct contact with the afflicted cells or, transfer heat to the afflicted cells through an intermediary.
Localized hyperthermia therapy is presently used in treating prostate afflictions, breast cancer, and other afflictions. This modality involves placing implants about the afflicted patient's afflicted cells, and then heating the implants by radiating EMF or ultrasonic energy thereto. The heat from the implants then migrates into the afflicted tissue, via conduction, thereby raising the temperature of the afflicted cells. Several issued patents demonstrate variations of this technique. Issues relating to possible adverse affects of exposure to both radiation, and radiated energy abound. However, as most suffers of prostate cancer are older men who are past the age of fathering children, and female breasts are relatively remote from the female reproductive organs, the possible long-term adverse collateral effects of using such radiant energy treatments are minimized.
Applicant has discovered various patents that employ and exemplify other energy transfer methods and media in creating localized hyperthermias. These patents include Guibert, U.S. Pat. No. 4,595,008, issued Jun. 17, 1986, and Shantha, U.S. Pat. No. 5,195,965 issued Mar. 23, 1993.
Various other heated liquid devices and methods of treating hollow organs or body orifices exist, and operate in the same basic manner. However, there is a need for a system and method for the creation of a localized therapeutic hyperthermia by means of a heated liquid directly contacting afflicted cells for a period of significant duration. More particularly, there is a need for a device, or method of treatment, which involves, selecting a therapeutic liquid, heating the selected liquid through conduction so as to avoid EMF or ultrasonic radiation, placing a therapeutic applicator about the afflicted cells, and circulating the heated fluid through the therapeutic applicator, thereby creating a localized hyperthermia in the afflicted cells within the circumference of the applicator. Furthermore it would be beneficial to provide the use of a localized hyperthermic modality in conjunction with Vacuum Assisted Closure™, (“V.A.C.®”) of open wounds. It is towards the fulfillment of these needs that the present invention is directed.